FDA applicant
Wuhan Pioon Technology Co., Ltd.
FDA records 8 decisions for Wuhan Pioon Technology Co., Ltd. (Wuhan, CN) from 2023 to 2026: 8 510(k) clearances. Most are in product codes GEX (Powered Laser Surgical Instrument) and NVK (Laser, Dental, Soft Tissue). Since 2016 its 510(k)s took a median of 58 days from receipt to decision, against 90 for FDA’s reviews in the same codes and years. Its devices cite 15 predicates, 5 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Wuhan Pioon Technology Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2023.
Planning a device like Wuhan Pioon Technology Co., Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report